MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new updated and corrected information is referenced within the update statements.Please refer to statement dated 06jun2019.No further follow up is planned.Evaluation summary the reporter stated the patient used the humapen ergo ii since approximately 2012.  there was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device. the patient used the humapen ergo ii for approximately seven years. the humapen ergo ii user manual states to not use the pen for more than three years after the first use.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) (at the time of initial report) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (humulin 70/30) from a cartridge via humapen 2 (ergo ii) subcutaneously with an unknown dose for treatment of diabetes mellitus starting on an unknown date.On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, he developed hypoglycemia (the blood glucose value was 2-3) and physical inactivity.The event of hypoglycemia was considered as serious due to its medical significance.Outcome for the event was and information regarding the corrective treatment was unknown.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.Follow-up was not possible as physician contact information was not provided and reporter refused to follow-up via phone.The operator of the humapen ergo ii and his/her training status was unknown.The general humapen ergo ii duration of use was not provided but the suspect device duration of use was approximately seven years.The suspect humapen ergo ii device was continued and was not returned to the manufacturer.The reporting consumer related the events and human insulin isophane suspension 70%/human insulin 30% drug whereas did not provide relatedness with the suspect humapen ergo ii device.Edit 16may2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 06jun2019: entered a device specific safety summary (dsss) for the humapen ergo ii.Updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8675970
• MDR Text Key: 147255814
• Report Number: 1819470-2019-00099
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1106D03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR